A consumer advocate group is calling for a ban on the 23mg Aricept dosage, which was approved by the FDA for more severe stages of Alzheimer's.

While Aricept is the mostly widely prescribed drug for the treatment of AD, it is most commonly prescribed in 5mg and 10mg doses. Its efficacy in controlling symptoms is only moderate, but it has been on the market for more than a decade and has a solid safety profile. The more recently approved, higher dosage of 23mg has been associated with a higher incidence of side effects and, according to the advocacy group Public Citizen, has no greater efficacy. The primary side effects are nausea, vomiting, and agitation.

It is unclear whether the FDA will act on the petition to review the data and reverse the former approval for this dosage. However, the most salient point for treating physicians to understand is that, regardless of the dosage, cholinesterase inhibitors like Aricept yield the most clinical benefit when prescribed as poly-therapy along with Namenda. The data supporting this clinical approach are clear and compelling.

This is interesting. At a time when partisanship seems to have reached a high in the US political process, at least one prominent Republican is calling for an increase in spending.

Specifically, as reported by NBC News, Newt Gingrich is making the case for dramatically increasing funding for AD research. I am sure that is not a popular position with his party, but it is the right long-term perspective.

To reiterate some statistics that are widely published, we spent about $6B of federal funds last year on cancer research, about $3B on HIV research, and only $500M on AD research. All are worthy causes, but the AD program is clearly underfunded.

This is especially true when considering the full economic argument that shows the enormous cost of caring for patients with diminished cognitive capacity. It is well documented that once memory and judgment begin to slip, patients become less effective at administering self-care, and their chronic conditions such as diabetes and hypertension often spiral out of control. This leads to poor health and stark increases in the costs of their care.

Spending on AD research can not only accelerate our progress toward better treatments but can facilitate a return to sustainability for the US health care system.

Eating well, staying fit, and using your brain have no effect on your risk for Alzheimer's? Many headlines have implied this dire message over the past 24 hours.

The source of these headlines is an article published in the Archives of Neurology, online edition. The article reviewed the evidence that actively managing modifiable factors could reduce the risk of AD, and concluded that only a low level of evidence suggests a relationship between the risks and the disease.

Let's be sure not to misunderstand this.

What is a "Low Level" of Evidence?
The authors classified the level of evidence for each risk factor in accordance with accepted scientific standards. These standards allow for three levels of evidence: low, medium, and high.

Importantly, a "low" level of evidence means that real research, conducted with sound methods, that was published in peer-reviewed medical journals, showed an association between the risk factor being studied and the incidence of AD. Perhaps the association was not overly strong, perhaps the sample size was small, perhaps similar studies have not been completed to verify the result, but even a "low" level of evidence is a pretty good start in finding a meaningful association.

The panel authoring this paper, on behalf of the National Institutes of Health, found a low level of evidence that diabetes, high cholesterol, and tobacco use all confer a higher risk of Alzheimer's disease. Sure we want more evidence and a higher level of confidence, but all work so far suggests that these are real risks that need to be managed.

The panel also found a low level of evidence that a Mediterranean diet, folic acid intake, light alcohol consumption, cognitive activity, and physical activity all reduced risks of Alzheimer's. That's more good news.

This review constitutes unbiased, expert confirmation that many modifiable risk factors should in fact be managed to reduce the risk of AD. The evidence is not as strong as we would all like, but it has reached a minimum threshold of scientific scrutiny to establish a likely association.

The problem here is the massive and consistent misinterpretation of these findings by the press. In every day jargon, a "low level of evidence" is a negative testimonial as to the likelihood of an association. But in the scientific world, where facts are closely scrutinized before they qualify as "evidence", a low level of evidence connotes a pretty good start toward proving a point. It is a shame that this is not understood by the major media outlets and is not more clearly represented in their publications.

No one can say with any degree of certainty if it will be approved or not, but as noted in an update provided by Fierce Biotech, there has been an interesting development in the progress of the clinical trial. The companies sponsoring the trial, Pfizer/Wyeth and J&J, amended the protocol last year to expand the study by several thousand research subjects. This is a very costly move in terms of research investment and time required to conclude the study, and has led to much speculation as to why the trial was expanded.

A leading theory that makes lots of sense, is tied to the recently revised guidelines for diagnosing Alzheimer's disease. Under the new guidelines, the presence of disease pathology can be recognized much earlier, when symptoms are much subtler, compared to the former standards. This bodes well for more effective treatment.

However, the new guidelines also create a potential conundrum in terms of currently approved treatments.

The FDA has approved 4 drugs for treating Alzheimer's, but all of those approvals are based on the former definition of the disease, that requires a later stage of disease progression and more severe symptoms before the diagnosis can be made. It is possible that the Bapineuzumab trial was initiated to demonstrate efficacy against the late stage disease that was defined in the old guidelines, but revised to demonstrate efficacy against an earlier stage of disease as defined in the revised guidelines.

Although the trial protocol was amended about a year before the new guidelines were released, a draft version of the revisions have been available and mounting industry consensus has been visible for quite some time.

If the drug works, and the trial sponsors can demonstrate that it works at very early stages of Alzheimer's, this could be a giant leap forward for the field.

The case for funding Alzheimer's research, and for participating in such research, is a compelling one.

You've all heard or read the numbers: more than 5 million Americans diagnosed, probably at least that many in early stages and not yest diagnosed, with all numbers approximately tripling by 2050. Neither our health care system nor our society can absorb the looming impact of this epidemic.

In this excellent opinion piece posted at CNN, Dr. Ronald Petersen of the Mayo Clinic describes an approach to averting a national, disease-driven crisis. I encourage you to click through and read it.

Many of you may have seen Larry King's CNN special last night on Alzheimer's disease. It was a one-hour special report on the urgency of the challenge this disease poses for our aging population, for our health care system, and for our society.

Overall, I thought there was a fair amount of good information presented. The expert testimonies from Dr. Ron Petersen at the Mayo Clinic and Dr. Jeffrey Cummings from the Cleveland Clinic were excellent and clearly characterized the nature and the magnitude of this epidemic. Heartfelt stories from care givers brought a very personal face to the disease and provided an in depth look at the way this disease can affect an entire family.

Having said that, I also thought the show performed one major disservice to the public. There was much dramatic emphasis on the fact that Larry King and Ron Reagan visited the Cleveland Clinic to be evaluated for early signs of Alzheimer's and Ron Reagan chose to forgo an evaluation based on his preference to remain "blissfully ignorant".

To be clear, everyone has the right to make such a decision and I don't begrudge Reagan his right to do so. However, he couched his decision against the backdrop that "there is no cure" and implied that it is therefore better "not to know" about the early presence of disease process. This is a myth we need to stop perpetrating and Larry King missed the opportunity to set the record straight.

While there is no cure for Alzheimer's disease, there is certainly treatment. Importantly, some people respond remarkably well to treatment, adding years of independence to their lives. Broadcasting the message that it is "better not to know", as King did last night, may prevent some people from gathering the facts and making a more informed decision,based on the knowledge that early intervention and appropriate treatment could be significantly beneficial.